EUCTR2017-003638-10-FR
Active, not recruiting
Phase 1
INTRANASAL CLONIDINE PREDICTION IN PEDIATRIC SURGERY: RANDOMIZED STUDY AGAINST PLACEBO - CLONIPREM
CHRU LILLE0 sites150 target enrollmentJanuary 12, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CHRU LILLE
- Enrollment
- 150
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Age of 1 to 5 years,
- •\- Weight from 10 to 25 kg
- •\- Signature of informed consent
- •\- ASA 1 or 2, (ANNEX 6\)
- •\- Scheduled minor surgery
- •\- Affiliation to Social Security
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 150
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
Exclusion Criteria
- •\- Failure to obtain consent,
- •\- Participation in another clinical trial involving a drug,
- •\- Known contraindications or hypersensitivity to clonidine, or to any of
- •the excipients,
- •\- Upper airway infection within 3 weeks prior to inclusion,
- •\- Intravenous Induction,
- •\- History of cardiac arrhythmia, congenital heart disease,
- •\- Mental retardation or psychoactive treatment.
Outcomes
Primary Outcomes
Not specified
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